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A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

This study has been completed.
Information provided by:
Clavis Pharma Identifier:
First received: July 9, 2007
Last updated: June 3, 2009
Last verified: January 2009
Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.

Condition Intervention Phase
Advanced Colorectal Cancer
Colorectal Cancer
Drug: CP-4055
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • • Objective response rate (RR) [ Time Frame: October 2008 ]

Secondary Outcome Measures:
  • • Time to progression (TTP) [ Time Frame: October 2008 ]
  • • Duration of tumor response [ Time Frame: October 2008 ]
  • • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population [ Time Frame: October 2008 ]

Enrollment: 16
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CP-4055
    CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion
    Other Name: ELACYT (TM)
Detailed Description:
This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed metastatic CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs)
  2. Measurable disease according to Response Criteria In Solid Tumours (RECIST)
  3. Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  4. Age 18 years or more
  5. Life expectancy > 3 months
  6. Signed informed consent (IC)
  7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to CP-4055 treatment. Nursing patients are excluded.
  8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
  9. Adequate haematological and biological functions

Exclusion Criteria:

  1. Known brain metastases
  2. Radiotherapy to more than 30 % of bone marrow
  3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  4. Concomitant treatment with a non-permitted medication:

    • Alternative drugs
    • High doses of vitamins
  5. History of allergic reactions to ara-C or egg
  6. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
  7. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
  8. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
  9. Known positive status for HIV and/or hepatitis B or C
  10. Drug and/or alcohol abuse
  11. Any reason why, in the investigator's opinion, the patient should not participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00498407

United Kingdom
Aberdeen Royal Infirmary, Foresterhill,
Aberdeen, United Kingdom, AB25 2ZN
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
Leicester, United Kingdom, LEI 5WW
Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Sponsors and Collaborators
Clavis Pharma
Principal Investigator: Jim Cassidy, MBChB, MD The Beatson West of Scotland Cancer Centre
  More Information

Responsible Party: Jean-Michel Gaullier, Clavis Pharma Identifier: NCT00498407     History of Changes
Other Study ID Numbers: CP4055-202
Grantor: CDER
IND/IDE Number: NA
Study First Received: July 9, 2007
Last Updated: June 3, 2009

Keywords provided by Clavis Pharma:
Colorectal cancer
Second line therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017